PMID- 29404713 OWN - NLM STAT- MEDLINE DCOM- 20180702 LR - 20240313 IS - 1129-2377 (Electronic) IS - 1129-2369 (Print) IS - 1129-2369 (Linking) VI - 19 IP - 1 DP - 2018 Feb 5 TI - Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. PG - 13 LID - 10.1186/s10194-018-0840-8 [doi] LID - 13 AB - BACKGROUND: OnabotulinumtoxinA is approved for the prevention of headache in those with chronic migraine (CM); however, more clinical data on the risk-benefit profile for treatment beyond one year is desirable. METHODS: The Chronic Migraine OnabotulinuMtoxinA Prolonged Efficacy open Label (COMPEL) Study ( ClinicalTrials.gov , NCT01516892) is an international, multicenter, open-label long-term prospective study. Adults with CM received 155 U of onabotulinumtoxinA (31 sites in a fixed-site, fixed-dose paradigm across 7 head/neck muscles) every 12 weeks (+/-7 days) for 9 treatment cycles (108 weeks). The primary outcome was headache day reductions at 108 weeks; secondary outcomes were headache day reductions at 60 weeks and change in the 6-item Headache Impact Test (HIT-6) score. Safety and tolerability were assessed by reviewing the frequency and nature of adverse events (AEs). AEs were determined at each visit through patient self-report, general non-directed and, for specific AEs, directed questioning, and physical examination. Subgroup analyses for safety and efficacy included, but were not limited to, patients with/without concomitant oral preventive treatment and acute medication overuse at baseline. RESULTS: Enrolled patients (N = 716) were 18-73 years old and most were female (n = 607, 84.8%). At baseline, patients reported an average 22.0 (SD = 4.8) headache days per month. 52.1% of patients (n = 373) completed the study. By 60 and 108 weeks, a significant reduction in headache days (- 9.2 days and - 10.7 days, respectively, P < 0.0001) was observed. Significant improvements (P < 0.0001) in HIT-6 scores (- 7.1 point change at week 108) were also demonstrated. 131 patients (18.3%) reported >/=1 treatment-emergent adverse events; most frequently reported was neck pain (n = 29, 4.1%). One patient reported a serious treatment-related adverse event (rash). No deaths were reported. CONCLUSIONS: The COMPEL Study provides additional clinical evidence for the consistency of the efficacy and for the long-term safety and tolerability of onabotulinumtoxinA for the prevention of headache in those with CM who have been treated with onabotulinumtoxinA every 12 weeks over 2 years (9 treatments) with the fixed-site, fixed-dose injection paradigm. TRIAL REGISTRATION: Trial registration number: NCT01516892 . Name of registry: clinicaltrials.gov . Date of registration: January 20 2012. Date of enrollment of first patient: December 2011. FAU - Blumenfeld, Andrew M AU - Blumenfeld AM AD - Headache Center of Southern California, The Neurology Center, 6010 Hidden Valley Road, Carlsbad, CA, 92024, USA. blumenfeld@neurocenter.com. FAU - Stark, Richard J AU - Stark RJ AD - Monash University and Alfred Hospital, Melbourne, VIC, Australia. FAU - Freeman, Marshall C AU - Freeman MC AD - Headache Wellness Center, Greensboro, NC, USA. FAU - Orejudos, Amelia AU - Orejudos A AD - Allergan plc, Irvine, CA, USA. FAU - Manack Adams, Aubrey AU - Manack Adams A AD - Allergan plc, Irvine, CA, USA. LA - eng SI - ClinicalTrials.gov/NCT01516892 PT - Clinical Trial PT - Journal Article PT - Multicenter Study DEP - 20180205 PL - England TA - J Headache Pain JT - The journal of headache and pain JID - 100940562 RN - 0 (Acetylcholine Release Inhibitors) RN - EC 3.4.24.69 (Botulinum Toxins, Type A) SB - IM MH - Acetylcholine Release Inhibitors/adverse effects/*therapeutic use MH - Adult MH - Aged MH - Botulinum Toxins, Type A/adverse effects/*therapeutic use MH - Chronic Disease MH - Double-Blind Method MH - Female MH - Follow-Up Studies MH - Humans MH - *Internationality MH - Male MH - Medical Records MH - Middle Aged MH - Migraine Disorders/*diagnosis/*drug therapy/epidemiology MH - Muscle Weakness/chemically induced MH - Neck Pain/chemically induced MH - Prospective Studies MH - Registries MH - Treatment Outcome PMC - PMC5799088 OTO - NOTNLM OT - Chronic migraine OT - Efficacy OT - Long-term OT - OnabotulinumtoxinA OT - Prophylaxis OT - Safety COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The study received ethical approval from the Institutional Review Board or Independent Ethics Committee at each site, and written informed consent was obtained from patients before study enrollment. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: Andrew M. Blumenfeld has served on advisory boards and/or has consulted for Allergan, Pernix, Teva, Avanir, Depomed, and Supernus, and has received funding for travel, speaking, and/or royalty payments from Allergan. Richard J. Stark has served on advisory boards and/or has consulted for Allergan, has served on advisory boards for Novartis and has received funding for travel and/or speaking payments from Allergan, MSD, AbbVie and SciGen, and from In Vivo Academy relating to a Pfizer-sponsored project. Marshall C. Freeman has served on advisory boards and/or has consulted or received research support from Alder, Allergan, Avani, Dr. Reddy's Laboratories, Eli Lilly, Scion, and Teva. Amelia Orejudos is an employee of Allergan plc. Aubrey Manack Adams is an employee of Allergan plc and owns stock in the company. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/02/07 06:00 MHDA- 2018/07/03 06:00 PMCR- 2018/02/05 CRDT- 2018/02/07 06:00 PHST- 2017/10/13 00:00 [received] PHST- 2018/01/19 00:00 [accepted] PHST- 2018/02/07 06:00 [entrez] PHST- 2018/02/07 06:00 [pubmed] PHST- 2018/07/03 06:00 [medline] PHST- 2018/02/05 00:00 [pmc-release] AID - 10.1186/s10194-018-0840-8 [pii] AID - 840 [pii] AID - 10.1186/s10194-018-0840-8 [doi] PST - epublish SO - J Headache Pain. 2018 Feb 5;19(1):13. doi: 10.1186/s10194-018-0840-8.